Gastro-occlusive device

ABSTRACT

A gastro-occlusive device, comprising a balloon disposable in a stomach cavity of a patient, and inflatable therein to occlude a portion of the volume of the stomach cavity, a gas flow tube coupled at a distal end thereof with the balloon and extending outwardly through a stomach wall for coupling with a gas source for selectively inflating the balloon, to occlude at least a portion of the volume of the stomach cavity. The gastro-occlusive device may be employed in combination with a feeding tube unit, a drain unit or other ancillary apparatus, and is useful for treatment of morbid obesity and various eating disorders.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a gastro-occlusive device, such as is usefulfor the treatment of morbid obesity and a variety of eating disorders.

2. Description of the Related Art

World-wide public health surveys and nutritional studies reflect acurrently high and growing incidence of obesity in many countries.

The reasons for such pervasiveness of overweight individuals arenumerous and include progressively increasing levels of sedentarybehavior, ubiquity of processed high-fat, high-carbohydrate foods,increased automation of formerly manual activities, and decreasedattention to physical fitness and exercise.

Although substantial efforts have been undertaken individually,governmentally and societally to ameliorate and reverse this trend,involving novel diets, food supplements, exercise equipment, nutritionalregulations, psychological and counseling-based approaches, engineeredfoods, and many other interventional actions, such efforts have failedto address this serious and growing problem.

This problem is particularly serious in the case of individuals who areseverely overweight (e.g., who exceed weight averages of applicableheight/weight norms by 50% or more). For this segment of the overweightpopulation, surgical intervention has been an increasingly preferredmode of resolving issues of excessive body weight. So-called “stomachstapling,” as a species of gastric reduction surgery, has become commonas a mode of treatment of morbid obesity. This intervention involvesclosing off an upper portion of the stomach so that ingestion of smallamounts of food produces satiety. In the surgical process termedvertical banded gastroplasty, the stomach is stapled vertically withrows of staples producing a reduced stomach volume typicallyconstituting only a few tenths of a liter. A band then may be stapled toboth walls of the stomach to prevent the stomach from stretching and tocontrol the size of the stomach outlet. The stomach thereby is madesmaller in volume, causing the patient to eat less while achieving afeeling of fullness, i.e., satiety.

Gastric reduction surgery has significant associated risks that impactits use and reliability. The stomach after the surgical procedure isstill able to stretch, and staples can break and require additionalemergency surgical intervention, since the detached staples may pose alife-threatening condition. Additionally, there are major side-effectsto the surgery, including death, stroke, diarrhea, nausea, vomiting,chronic heartburn, and vitamin deficiencies. A significant portion ofindividuals who undergo gastric reduction surgery require a secondoperation to correct the side effects. There are other forms of gastricsurgery, including laparoscopic adjustable gastric banding, whichlikewise has significant post-operative side effects.

Thus, although gastric reduction surgery is effective in many instancesto provide a reduction in food intake and consequently of weight of theindividual, it nonetheless carries significant health and safety risksthat limit its use as a treatment option for morbid obesity.

It would therefore be a significant advance in the art to provide analternative to gastric reduction surgery for the treatment of morbidobesity, which avoids the associated health and safety risks ofconventional gastric reduction surgery.

SUMMARY OF THE INVENTION

The present invention relates to a gastro-occlusive device.

In one aspect, the present invention relates to a gastro-occlusivedevice, comprising a balloon disposable in a stomach cavity of apatient, and inflatable therein to occlude a portion of the volume ofthe stomach cavity, a gas flow tube coupled at a distal end thereof withthe balloon and extending through a stomach wall to a proximal end thatis at or in interior proximity to a surface of the patient's body orextends exteriorly out of the patient's body, and means for selectivelyinflating the balloon, coupled to the gas flow tube at the proximal endthereof and arranged to flow inflation gas to the balloon in thepatient's stomach cavity, for said inflation therein to occlude at leasta portion of the volume of the stomach cavity.

In another aspect, the invention relates to a method of treating asubject in need of treatment for an eating disorder or overweightcondition, said method comprising disposing in the stomach of thesubject a balloon that is inflatable to occlude at least a portion ofinterior volume of the stomach, wherein the balloon is coupled by a gasflow passage to an actuatable source of inflation gas, and actuating thesource of inflation gas to flow gas into the balloon for inflationthereof to occlude at least a portion of the interior volume of thestomach, to an extent producing satiety with reduced intake ofnutrition, relative to a corresponding subject lacking the inflatedballoon in the subject's stomach.

Other aspects, features and embodiments of the invention will be morefully apparent from the ensuing disclosure and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a gastro-occlusive device, with anoptional feed tube assembly according to one embodiment of theinvention.

FIG. 2 is a schematic view of a gastro-occlusive device according toanother embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION. AND PREFERRED EMBODIMENTS THEREOF

The present invention is based on the discovery that a gastro-occlusivedevice can be formed as an inflatable balloon article for positioning inthe stomach of a patient in need of gastric reduction for combatingovereating, wherein the inflatable balloon article positioned in thestomach cavity and coupled with exteriorly disposed structure allowingselective inflation and deflation of the balloon article to adjust theworking volume of the stomach.

By selective inflation, the user can cause the expanded volume of theballoon article to occupy a major portion of the stomach volume, wherebysatiety is achieved in a manner analogous to gastric reduction surgery,but without the necessity of banding or stapling the stomach, with theattendant side effects and risks of such surgery.

The stomach may for example have a volume of 1.5 liters and a capacityof 3 liters when expanded. By disposing an inflatable balloon article inthe stomach cavity that is selectively inflatable to occlude a majorfraction of such stomach volume, e.g., at least 50%, at least 75%, atleast 95%, or up to even 100% occlusion levels, the ingestion of foodnecessary to reach satiety is correspondingly reduced. If necessary fornutritional or medical reasons, the balloon can be selectively deflated,or alternatively maintained in an inflated state with periodicreinflation of the balloon as needed to maintain the expanded volume forocclusion of the stomach volume.

The invention in another embodiment utilizes the inflatable balloonocclusive device in combination with a feeding tube, drainage tube orother additional device, in an assembly providing for selectivevariation of the operative stomach volume and ingress/egress of materialas needed.

In one specific embodiment, the feeding tube can be refunctionallydeployed as a withdrawal tube to withdraw material from the stomach,subsequent to feeding, to assist the limitation of nutritional materialto the patient.

The disclosures of U.S. patent application Ser. No. 10/622,275 filedJul. 18, 2003 in the name of Tilak M. Shah for “INFLATABLE DUAL BALLOONCATHETER,” U.S. patent application Ser. No. 10/815,282 filed Apr. 1,2004 in the name of Tilak M. Shah for “EXTRUSION LAMINATE POLYMERIC FILMARTICLE AND GASTRIC OCCLUSIVE DEVICE COMPRISING SAME,” U.S. Pat. No.6,712,832 issued Mar. 30, 2004 in the name of Tilak M. Shah for“LOW—PRESSURE MEDICAL BALLOONS AND METHOD OF MAKING SAME,” U.S. Pat. No.6,663,646 issued Dec. 16, 2003 in the name of Tilak M. Shah for“ISOTROPICALLY EXPANSIBLE BALLOON ARTICLES USEFUL IN IN VIVO LUMENALPROCEDURES AND METHOD OF MAKING SUCH BALLOON ARTICLES,” U.S. Pat. No.6,460,541 issued Oct. 8, 2002 in the names of Tilak M. Shah and Deszo K.Levius for “HEAT-SEALED INFLATABLE ARTICLE AND METHOD OF MAKING SAME,”and U.S. Pat. No. 5,833,915 issued Nov. 10, 1998 in the name of Tilak M.Shah for “METHOD OF WELDING POLYURETHANE THIN FILM,” hereby areincorporated herein in their respective entireties, for all purposes,and are jointly referred to hereinafter as the “Shah, et al. PatentDisclosures.”

The balloon article can advantageously be formed as a gas barrier filmstructure constituting a laminate including a layer of sealing film,having main top and bottom surfaces; and a layer of thermoplasticpolymer film, laminated (e.g., extrusion laminated) to the layer ofsealing film, on at least one of the main top and bottom surfaces, inwhich the sealing film has a composition and thickness imparting gasbarrier character to the multilayer film and wherein the layer(s) ofthermoplastic polymeric material alone lacks such gas barrier character,as more fully described in the aforementioned U.S. patent applicationSer. No. 10/815,282 filed Apr. 1, 2004 in the name of Tilak M. Shah for“EXTRUSION LAMINATE POLYMERIC FILM ARTICLE AND GASTRIC OCCLUSIVE DEVICECOMPRISING SAME.”

The balloon may be fabricated as more fully described in theaforementioned U.S. Pat. No. 6,712,832 issued Mar. 30, 2004 in the nameof Tilak M. Shah for “LOW—PRESSURE MEDICAL BALLOONS AND METHOD OF MAKINGSAME,” in which a low-pressure medical balloon is fabricated byproviding a thin film of thermoplastic polymeric material that is heatedto a sufficient temperature for vacuum forming thereof. A firsthalf-section for the balloon is formed by subjecting the thermoplasticpolymeric film to vacuum suction. A second half-section for the balloonthen is formed by subjecting a same or different thermoplastic polymericthin film to vacuum suction, following which the first half-section ofthe balloon is bonded to the second half-section along respective edgesthereof to yield the balloon.

Additionally, or alternatively, the balloon article can be fabricatedand can be constituted materials-wise, as more fully otherwise describedin the Shah et al. Patent Disclosures.

Referring now to the single drawing, FIG. 1 is a schematic view of agastro-occlusive device according to one embodiment of the invention.

The gastro-occlusive device and feed tube assembly 10 includes agastro-occlusive device 12, and is optionally in combination with afeeding tube unit 14 (or other additional device such as a drain tube).The gastro-occlusive device 12 includes an inflatable balloon 20 at thedistal end of gas tube 18, as illustrated. The balloon and the gas tubemay be separately formed and subsequently coupled with one another,e.g., by RF welding, adhesive bonding, etc., or alternatively theballoon and the gas tube may be integrally formed as a single-piece itemby extrusion, blow molding, dip molding, casting, etc.

The balloon 20 is formed of a film material, e.g., of polyurethane,silicone or other polymeric material, e.g., synthetic elastomer, and isfabricated in any suitable manner, as for example as variously describedin the Shah et al. Patent Disclosures. The gas tube 18 may be formed ofa same or different material. The balloon may be formed in any suitablemanner, including, without limitation, film welding, dip molding, blowmolding, LIM molding, rotomolding, or any other suitable techniqueappropriate to the material of construction.

The balloon 20 is shown disposed in a deflated state in the stomachcavity 42 of the stomach 30 of a patient, with the gas tube 18 coupledto the balloon, and extending through the wall of the stomach 30, beingretained in position by exterior flange member 38 and interior flangemember 40, which may be interlocking with one another, or otherwisesecured in relation to the stomach wall, so as to keep the gas tube 18seated in passage through the stomach wall, and fixedly positioned (itbeing understood that normal movement of the stomach will occur, alongwith contraction and expansion of the stomach due to the peristalticmusculature thereof).

The gas tube 18 extends outwardly from the stomach and through thedermal wall 32 shown schematically in FIG. 1. The gas tube ispositionally secured at the dermal wall 32 by exterior flange member 34and interior flange member 36, which as in the case of flange members 38and 40, may be interlocking with one another, or otherwise secured inanchoring relation to the dermal wall, so as to keep the gas tube 18sealed in passage through the dermal wall, and fixedly positioned (itbeing understood that normal movement of the dermal wall will likewiseoccur).

Optionally, the gas tube 18 in a specific embodiment extends exteriorlyof the patient's body as illustrated, and is connected to a squeeze bulb16. The squeeze bulb 16 can be manually repetitively squeezed in apumping fashion to flow air from the ambient environment of the patientinto the gas tube 18 for flow therethrough into the balloon 20, forinflation of the balloon from the deflated state depicted in thedrawing, to the inflated state shown by dashed line 44. In the inflatedstate, with the balloon expanded to the volume indicated by the dashedline 44, the balloon occludes most of the stomach cavity volume.

Alternatively to the use of a squeeze bulb as illustrated, the balloonocclusive device may feature the gas tube as having the associatedstructure shown in dashed line representation in FIG. 1, pursuant towhich the gas tube terminates at a coupling member 52 in cap 50, towhich a matably engageable coupling 54 having a tube segment and squeezebulb associated therewith, can be attached. In this manner, the squeezebulb can be selectively attached to and removed from the coupling member52 of the cap 50. Alternatively, such coupling 52 may be constructed forengagement with a gas supply at a physician's office or in a carefacility, so that the inflation and deflation of the balloon iscontrolled by a medical practitioner, to avoid any patient complianceissues. The elimination of an always-connected squeeze bulb alsoimproves the ease of use and lifestyle of the patient.

With the balloon in the inflated state, the patient can ingest food in anormal manner, but due to the restricted volume of the stomach due tothe occlusive character of the balloon, the patient will experiencerapid onset of satiety, as the ingested food fills the limited stomachvolume.

Subsequent to onset of satiety and loss of the hunger impulse by thepatient, the balloon 20 can be deflated from its inflated stateindicated by dashed line 44, to the deflated state indicated in solidline representation in the FIG. 1 drawing. For example, the squeeze bulb16 may be constructed with a stop-cock or valve on its proximal end,which can be adjusted by the patient or a medical assistant to permitthe squeeze bulb to be switched to an evacuation mode, for pump-down ofthe balloon in the patient's stomach.

Alternatively, as noted, the coupling 52 may be adapted for attachmentto a dedicated air or other gas supply administered by a physician orother healthcare personnel, to avoid any issues of patientnon-compliance.

Alternatively, the balloon may be retained in the inflated state for anextended period of time, to provide ongoing occlusive action by theballoon in the stomach of the patient, and restrict the intake of foodby the patient for a sustained period of time.

The balloon article and associated inflation/deflation means andconnecting tubing and positioning means, as above described, may beprovided as a unitary device in one embodiment of the invention.

Optionally, as illustrated, an additional device, such as theillustrated feeding tube unit 14, or alternatively a drain tube or otherstructure or device, may additionally be provided.

It will therefore be appreciated that the drawing of the inventivesystem in FIG. 1 has been drawn to show both the balloon article and thefeeding tube unit, for economy of illustration, as schematicallydepictive of both (1) the embodiment of the invention wherein theballoon article and associated infrastructure for inflation anddeflation, without provision of the feeding tube unit, and (2) anoptional embodiment of the invention wherein the balloon article andassociated infrastructure for inflation and deflation are provided incombination with a feeding tube unit.

The feeding tube unit 14 as illustratively shown in FIG. 1 includes atube 24 which in the specific depicted embodiment is joined in fluidsupply relationship at its proximal end to the fluid supply bag 26. Thetube 24 extends through a sidewall of the gas tube 18 as shown anddistally thereof is interiorly disposed in and coaxial with the gas tube18. Thus, the tube 24 extends through the lumen of gas tube 18 to thedistal end 22 of the balloon 20, at which terminus the tube 24 has anopen end, permitting the efflux from the tube 24 of fluid flowed throughthe tube 24 from the fluid supply bag, under the action of the pump 28,which may be of any suitable type, e.g., a peristaltic pump.

The feeding tube unit 14 therefore may be arranged to actuate the pump28 and flow nutrient fluid from the bag 26 though tube 24 to the opendistal end 22 of the balloon, when the balloon is in a deflatedcondition, and with subsequent inflation of the balloon serving to closesuch open distal end 22 by the pressure of the inflation air introducedinto the balloon by the action of the squeeze bulb 16. For such purpose,the distal end 22 may be formed with a self-sealing valve, e.g., of thetype described in U.S. Pat. No. 6,460,541 issued Oct. 8, 2002 in thenames of Tilak M. Shah and Deszo K. Levius for “HEAT-SEALED INFLATABLEARTICLE AND METHOD OF MAKING SAME.” Alternatively, the feeding tube unitmay be arranged to flow nutritive material to the stomach when theballoon is inflated, so that there is no “pinch-off” effect exerted onthe tube at its open end by the inflated balloon.

The gastro-occlusive device and feed tube assembly 10 shown in FIG. 1may also be constructed and arranged so that the pump 28 is reversiblein character, and that when the balloon is deflated and the stomachcavity contains nutrient material, the stomach contents can be pumpedout of the stomach cavity by exertion of suction at the open distal end22 of the balloon 20. In such reverse mode of operation, in place of thefluid supply bag 26, a collection reservoir may be provided, forcollection and final disposition of the evacuated contents of thestomach cavity.

Further, although the tube 24 is shown as being internally disposed inthe gas tube 18, it will be appreciated that the tube 24 may beexternally disposed on the surface of the gas tube, or otherwise part ofa double lumen tube, having respective passages connecting with fluidsupply and inflation gas supply means.

As a still further alternative, the gastro-occlusive device assembly maycomprise a triple lumen or other multi-lumen tube, in which one lumen isconnected to the fluid supply bag, or to a drain, another is connectedor connectable to the squeeze bulb or other air supply means, and athird connects to a small ancillary balloon to anchor the gas tube (gassupply catheter) to the skin wall, and such third lumen for such purposeconnects or is connectable to the air supply means.

As mentioned, the occlusive device in lieu of a squeeze bulb 16 mayalternatively employ a dedicated pressurized gas supply, such as apressurized air tank, or other means, effective to supply air or othergas under pressure to inflate the balloon to a predetermined, ordesired, extent. A cap 50 may be employed in connection with couplingstructure for connection to the gas supply. In like manner, the cap 50may employ a coupling member 56 at which the feeding tube portionextending into the patient's stomach, is terminated, with a matablyengageable coupling member 58 joinable to the coupling member 56. Thecoupling member 58 thereby is attachable to and detachable from thecoupling member 56, to connect or alternatively disconnect the feedingtube, as desired.

As a further embodiment, the balloon 20 may also have a regulator orother gas flow control means (not shown in FIG. 1) associated therewith,to prevent over-inflation of the balloon in the stomach cavity. As yetanother variation, the gas tube 18 may have coupled therewith a pressuregauge 60 displaying the pressure in the balloon, and optionallyadditionally including an indication of the extent of fill of theballoon (e.g., on a scale of 0-100%) so that the inflation gas may beintroduced to a desired extent, as regards the volume of the stomachcavity that is desired to be occluded in a given use of the balloon inthe inflated state.

FIG. 2 is a schematic view of a gastro-occlusive device 70 according toanother embodiment of the invention.

The gastro-occlusive device 70 includes a silicone membrane 72 thatforms with the associated silicone rubber port member 74 a one-wayself-sealing valve that is disposed below the patient's skin 64, asillustrated. The port member 74 in turn communicates with the gas tube(catheter) 76, which passes through the wall of the patient's stomach 66and into the interior volume 68 of the stomach. The gas tube 76 iscircumscribed by an associated balloon 82 shown in the deflated state insolid line representation and in dashed line representation by dashedline 84 in the inflated state.

The balloon 82 is inflated by ingress of gas to the tube 76 from asyringe or gas injector with a penetration element such as a hollowneedle that is inserted through the membrane 72, following which air isinjected into the port member 74 and flows through the tube 76 into theportion of the tube that is disposed in the stomach of the patient. Theinjected air flows through gas flow openings 78 and 80 to inflate theballoon 82. Following inflation of the balloon to a desired extent, thesyringe or gas injector penetration element is withdrawn from the portmember through the membrane 72, which thereupon self-seals, to maintainthe inflation pressure in the balloon at a desired level.

Subsequently, if it is desired to deflate the balloon, a hollowpenetration element is inserted through the membrane 72 to allow effluxof gas from the balloon and gas tube, through port member 74 and thepenetration element. Following deflation, the penetration element iswithdrawn from the port member through the membrane, to permit resealingof the membrane to thereafter maintain the balloon in a deflated state.

The balloon and gas tube, as in previously described embodiments, can beformed of any suitable polymeric or other material of construction. Forexample, these elements may be formed of polyurethane, or alternativelyof silicone. Silicone construction of the balloon may require that theballoon be more frequently inflated to compensate for decliningpressure, since silicone thin film is typically more gas permeable thanpolyurethane, but silicone balloons can be employed that hold theirpressure, once inflated, for a sustained period of days. For example, inuse, wherein silicone balloon construction is utilized, it may bedesired for a patient to visit a doctor's office at a periodic interval,for reinflation of the balloon to compensate for the diminution ofpressure (and extent of inflation) of the balloon over time, from aninitial inflated pressure level.

Since the gastro-occlusive device shown in FIG. 2 is internal, andintroduction of inflation gas is by injection through the patient'sskin, the cosmetic appearance of the user's body is unaffected, andinsertion of the device may be effected by laparoscopic techniques, inan minimally invasive manner, without the potentially severedisadvantages and side effects of stomach stapling procedures.

It will therefore be appreciated that the gastro-occlusive device may bevariously configured and accessorized, with or without an associatedfeeding tube unit, as desired, and that such feeding tube unit whenpresent, may likewise be variously configured and accessorized, toprovide a therapeutically effective and reliable apparatus for treatmentof morbid obesity and eating disorders of widely varying type.

The gastro-occlusive device of the invention, and the feeding tube unitwhen employed therewith, may be readily installed in the body of thepatient, using minimally invasive laparoscopic techniques for theinsertion of the balloon, optional feeding tube, and associated gas tubeand anchoring members in the stomach of the patient.

Thus, while the invention has been variously described hereinabove withreference to specific aspects, features and embodiments, it will berecognized that the invention is not thus limited, but rather extends toand encompasses other variations, modifications and alternativeembodiments, such as will suggest themselves to those of ordinary skillin the art based on the disclosure herein. Accordingly, the invention isintended to be broadly construed and interpreted, as encompassing allsuch variations, modifications and alternative embodiments, within thespirit and scope of the claims hereinafter set forth.

1-33. (canceled)
 34. A gastro-occlusive device, comprising a balloondisposable in a stomach cavity of a patient, and inflatable therein toocclude a portion of the volume of the stomach cavity, a gas flow tubecoupled at a distal end thereof with the balloon and extending through astomach wall to a proximal end that is at or in interior proximity to adermal wall of the patient's body or extends exteriorly out of thedermal wall of the patient's body, and means for selectively inflatingthe balloon, coupled to the gas flow tube at the proximal end thereofand arranged to flow inflation gas to the balloon in the patient'sstomach cavity, for said inflation therein to occlude at least a portionof the volume of the stomach cavity, wherein the dermal wall and thestomach wall are in spaced relationship to one another, and wherein thegas tube is positionally anchored at both the stomach wall and thedermal wall of the patient.
 35. The gastro-occlusive device of claim 34,wherein said balloon is formed of a thin film polymeric material. 36.The gastro-occlusive device of claim 34, wherein said polymeric materialcomprises a material selected from the group consisting of polyurethaneand silicone.
 37. The gastro-occlusive device of claim 34, wherein theproximal end of the gas flow tube is joined to a cap at the surface ofthe patient's body, and said cap includes coupling members to which themeans for selectively inflating the balloon are connected.
 38. Thegastro-occlusive device of claim 34, wherein the proximal end of the gasflow tube is coupled exteriorly of the patient's body to said means forselectively inflating the balloon.
 39. The gastro-occlusive device ofclaim 34, wherein the means for selectively inflating the balloon areselected from the group consisting of a manually operable squeeze bulband a pressurized gas supply.
 40. The gastro-occlusive device of claim34, wherein the means for selectively inflating the balloon are arrangedfor selectively deflating the balloon subsequent to selectivelyinflating it.
 41. The gastro-occlusive device of claim 34, incombination with a feeding tube unit, wherein the feeding tube unitcomprises a nutritive fluid supply coupled with a feeding tube, and thefeeding tube is arranged with its distal end disposed in the stomachcavity of the patient.
 42. The gastro-occlusive device of claim 41,wherein the feeding tube is interiorly disposed in the gas flow tubewith the body of a patient.
 43. The gastro-occlusive device of claim 34,wherein the balloon when inflated occupies about 50% to about 100% oftotal volume of the stomach cavity of a patient.
 44. Thegastro-occlusive device of claim 34, wherein the balloon when inflatedoccupies at least 95% of total volume of the stomach cavity of apatient.
 45. A method of treating a subject in need of treatment for aneating disorder or overweight condition, said method comprisingdisposing in the stomach of the subject a balloon that is inflatable toocclude at least a portion of interior volume of the stomach, whereinthe balloon is coupled by a gas flow passage to an actuatable source ofinflation gas, and actuating the source of inflation gas to flow gasinto the balloon for inflation thereof to occlude at least a portion ofthe interior volume of the stomach, to an extent producing satiety withreduced intake of nutrition, relative to a corresponding subject lackingthe inflated balloon in the subject's stomach, wherein the stomach isdefined by a stomach wall, said gas flow passage is at or in interiorproximity to a dermal wall of the subject's body or extends exteriorlyout of the dermal wall of the subject's body, said dermal wall and thestomach wall are in spaced relationship to one another, and said gasflow passage is positionally anchored at both the stomach wall and thedermal wall of the subject.
 46. The method of claim 45, wherein theballoon when inflated occupies about 50% to about 100% of total volumeof the stomach cavity of a patient.
 47. The method of claim 45, whereinthe balloon is inflated to occlude at least 95% of total volume of thesubject's stomach.
 48. The method of claim 45, wherein the subject'sstomach is supplied by a feeding tube with nutrition.
 49. The method ofclaim 45, wherein the nutrition is supplied when the balloon is in adeflated state.
 50. The method of claim 45, wherein the nutrition issupplied when the balloon is in an inflated state.
 51. Agastro-occlusive device, comprising a balloon disposable in a stomachcavity of a patient, and inflatable therein to occlude a portion of thevolume of the stomach cavity, a gas flow tube coupled at a distal endthereof with the balloon and extending through a stomach wall to aproximal end that is at or in interior proximity to a surface of thepatient's body or extends exteriorly out of a dermal wall of thepatient's body, and means for selectively inflating the balloon, coupledto the gas flow tube at the proximal end thereof and arranged to flowinflation gas to the balloon in the patient's stomach cavity, for saidinflation therein to occlude at least a portion of the volume of thestomach cavity, wherein the gas flow tube is a single lumen tube. 52.The gastro-occlusive device of claim 51, wherein the means forselectively inflating the balloon are selected from the group consistingof a manually operable squeeze bulb and a pressurized gas supply. 53.The gastro-occlusive device of claim 51, wherein the means forselectively inflating the balloon are arranged for selectively deflatingthe balloon subsequent to selectively inflating it.